Director, Operational Readiness CQV

Company Description

CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution.

CRB is looking for an energetic, self-motivated individual for the role of Director, Operational Readiness. The Director will lead cross-functional teams in the integration and delivery of Operational Readiness services (Turnover, CQV, and Startup Operations) on capital projects for our Life Science, Food & Beverage, Semi-Conductor, and Data Center clients. Their main focus will be to become a business partner with Client’s in achieving a “Make Product Faster” mindset which enables licensable facilities to be production online, sooner utilizing risk-based and lifecycle methodologies.

This role will also include helping clients navigate through regulatory requirements, devising and executing strategies that meets timelines, and assessing / mitigating risk – all while driving leaner processes to achieve the end goal. The Director will provide oversight, guidance, and team formation for all regional projects from business development to proposal stage, to facility turnover. This position requires a high level of organization, communication, and leadership;

and the qualified candidate will have excellent interpersonal skills with internal and external clients. They will represent CRB in a professional manner, assist in winning work, and understand how their strategy directly impacts our collective success.

• Maintain P+L responsibilities for business team and accountable to achieve Regional Team Revenue and Profit goals
• Coordinate/collaborate with Regional leadership in business development and account management on Market Focus, Trends, and developing New Client Solutions
• Lead and Support the Operational Readiness approach internally and externally with client’s Design, Operations, Quality, and Regulatory teams
• Manage regulatory reviews, be part of operational design reviews, develop overall risk-based approach for testing/documentation
• Active management of internal and/or external Operational Readiness resources on projects
• Lead the development of specific Turnover, Operation, and CQV plans to ensure integration with design, automation and construction plans
• Work with Construction and Digital Innovation to deliver streamlined data management across various platforms
• Manage our partners and/or build a group to execute the integrated delivery strategy
• Develop and maintain relationships with ley stakeholders for successful projection execution
• Collaborate/Support the Digital Innovation team in the delivery of project data to Client’s using best practices and AI integration
• Future – assist in regulatory filings and agency reviews; operational training/staffing for clients
• Knowledge of US FDA (21 CFR 210, 211, 810), ISO 9001, and EU EMEA regulations
• Knowledge of primary industry guidance on CQV and CSV, including but not limited to:
  • ISPE Baseline Guide 5 Commissioning and Qualification, edition 2
  • ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
  • ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • ISPE Guideline Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
  • ISPE Good Practice Guide Applied Risk Management for Commissioning and Qualification, 2011

• Bachelor’s Degree in Architecture, Engineering, Life Sciences, Construction Management, or similar degree preferred, or equivalent years of relevant industry experience.
• Professional licensure strongly preferred.
• Minimum of 15+ years of Commissioning, Qualification, Validation, Compliance, and Operations experience in the…